Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

This study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in minority populations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18 years of age or older at time of signing informed consent

Patients who self-report as African American, Non-Hispanic White

Patients who present to the gastrointestinal (GI) clinic, surgery, or endoscopy at a participating Florida Pancreas Collaborative (FPC) site or the University of Mississippi Medical Center (UMMC) with a clinical suspicion or diagnosis of a pancreatic tumor.

Disqualifiers

Patient under 18 years of age

Has no suspicion or diagnosis of a pancreatic cancer or tumor

Self-reported race/ethnicity other than African American or Non-Hispanic White.

Trial population

Patients at a Florida Pancreas Collaborative site who identify as African American or Non-Hispanic White.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood Sample Collection

    Other intervention

    Participants will have 40 mL of blood drawn at baseline/pre-treatment. The study team will aim to have this blood collected at the time of standard of care blood draw if possible.

  • Tissue Sample Collection

    Other intervention

    At the time of tissue biopsy or surgical resection (if applicable) pancreatic tumor tissue, fat, tissue from site of metastasis, and cyst fluid (if applicable) will be collected.

  • Data Collection

    Other intervention

    Participants will complete a study questionnaire at baseline that includes medical history, lifestyle, and family history information.

  • Medical Image Collection

    Other intervention

    Medical images that are obtained during routine care such as computed tomography (CT) scans, magnetic resonance imaging (MRIs) and ultrasounds will be reviewed by the study team throughout the participant's medical care.

Treatment groups

125 Participants
are divided into 2 treatment groups
Group A: Retrospective Cohort0 interventions
Group B: Prospective Cohort4 interventions

Trial outcomes

Primary outcomes

1

Assess molecular and radiological landscape of traditional PDAC tumors in the context of Race/Ethnicity

Investigators will compare gene prevalence, type and expression of genetic mutations and radiomic features in African American participants vs Non-Hispanic White participants

Time frame
at 36 months
2

Compare biological properties of Adipose Tissue dysfunction

Investigators will compare biological properties of Adipose Tissue dysfunction between African American vs Non-Hispanic White participants.

Time frame
at 36 months
3

Examine the role of Adipose Tissue and PDAC tumor interactions in influencing tumor growth, metastasis, and therapeutic response

Investigators will compare the biological interactions of Adipose Tissue and PDAC tumor growth between African American vs. Non-Hispanic White participants to develop new and/or targeted drug combinations.

Time frame
at 36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

United States Department of Defense

Collaborator